Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.
Immunological methods are more reliable and easier to use as compared with the conventional methods of histological staining for identifying remnant stumps likely to be of some proprioceptive benefit after an ACL injury. Such an identification might help us preserve certain remnant stumps during ACL reconstruction which might in turn improve the postoperative functional outcomes.
Background:Foot involvement in osteoarticular tuberculosis is uncommon and isolated bony involvement of foot bones with an osteolytic defect is even more rare; diagnostic and therapeutic delays can occur, worsening the prognosis. We present a retrospective series of osteolytic variety of foot tuberculosis.Materials and Methods:We present 24 osteolytic variety of foot tuberculosis (Eleven calcaneus, four cuboid, two cunieforms, one talus, three metatarsals, three phalanges) out of 92 foot TB cases collected over last 20 years. There were 16 adults and eight children. Tissue diagnosis was established in 23 of 24 cases based on PCR AFB staining, culture, and histopathology. Surgical intervention was reserved for patients with either a juxtaarticular focus threatening to involve a joint or an impending collapse of a midfoot bone with cystic destruction.Results:Fifteen cases had an osteolytic lesion on the radiographs resembling a space-occupying lesion, five had patchy osteolysis, while four showed coke like sequestra; one patient had a lesion in two bones. Antitubercular chemotherapy after biopsy was sufficient to heal the lesion in 19 cases, while in five cases surgical debridement needed to be done. The lesions healed eventually. At an average followup of 8.3 years, (range 2-15 years) there were no recurrences and all patients were free from pain, with no restriction of movements. Six patients complained of occasional pain during walking on uneven ground.Conclusion:When tuberculous pathology is limited to the bone, the prognosis is better than in articular disease, as there is less deformity, and hence, less residual pain and disability.
Despite the fact that the calcaneus is the commonest tarsal bone fractured, many controversies exist in the literature regarding the management options. This stems from the fact that the understanding of the fracture pattern has evolved only recently, surgical approaches have lately been standardized, surgical timing has become more clear, and newer implants are regularly being introduced. Despite the significant advances, complications and controversies related to this common fracture abound. The present paper looks at all aspects of modern management options of calcaneus fractures and tries to review the literature with regard to the controversial issues that still persist.
ORIF for PCL avulsion fractures of tibia results in stable fixation, early mobilization and good functional outcomes. Although ORIF done acutely leads to best clinical outcomes, a delay in presentation (>3 weeks) does not necessarily contraindicate ORIF. An occult injury to PCL usually leads to inferior outcomes and primary PCL reconstruction should be considered as a viable option in these patients.
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